Package insert – Dr long’s enlarge capsules

Scheduling status: (not required with this submission)

Proprietary name (and dosage form): Dr long’s enlarge (capsules)

Composition:
Each capsule contains:
Maca – 500mg, siberian ginseng – 500mg, l-arginine – 180mg, epimedium (horny goat weed) – 80mg, cnidium fructus – 80mg, catuaba – 60mg, niacinamide – 10mg

Pharmacological classification: a 32.16 – others

Pharmacological action: (not required with this submission)

Indications:
Dr long’s enlarge capsules are indicated as a general supplement for increasing sexual performance and libido.
Maca is historically known for its properties to promote sexual vitality, as well as to increase energy levels and improve general life outlook. Maca is known to increase feelings of sexual desire in healthy men.
Siberian ginseng has adaptogenic properties, with increase of endurance and resistance to environmental stress. It is also used as an immune system stimulant with an increase in lymphocytes and immuno-modulation.

L-arginine is used for erectile dysfunction and male infertility, and for male sexual dysfunction. It assists with the nitric oxide (no) formation in the body causing vasodilation. Only with sufficient levels of no is the body ably to maintain an erection.
Epimedium (horny goat weed) is historically known as a sexual stimulant (aphrodisiac).
Cnidium fructus is used for increasing sexual performance and libido, erectile dysfunction, infertility, body building and to increase energy. The constituents in Cnidium have a relaxing effect on the corpus cavernosum, facilitating penile erection.
Catuaba is used as an aphrodisiac, for male sexual impotency as well as exhaustion and fatigue.
Niacinamide (b3) is used for peripheral vascular disease promoting relaxation and improving orgasm.

Contra-indications:
Hypersensitivity to any of the ingredients. Hypertension – products containing ginseng are not recommended for persons with uncontrolled high blood pressure (in excess of 180/90mm hg).

Warnings:
Persons with low blood pressure should use with caution as horny goat weed may lower blood pressure.

Interactions:
Persons on chronic medication could possibly discuss with their practitioner any possible interactions of the active ingredients listed hereunder.

Maca: none known. Siberian ginseng: alcohol – may have an additive sedative effect with alcohol. Anti-coagulant and anti-platelet drugs – concomitant use may increase the risk of bleeding. Barbiturates – concomitant use may increase the sedative effects of barbiturates. Cns depressants – concomitant use may cause addictive effects and increased sedation. Anti-diabetes drugs – possible hypoglycaemic activity, so monitor blood glucose levels closely. Cytochrome p450 substrates – evidence may suggest the activity of these may be inhibited. L-arginine: antihypertensive drugs – concommitant use may cause additive hypotensive effects.nitrates – concommitant use may cause additive vasodilation and have hypotensive effect. Horny goat weed (epimedium): antihypertensive drugs (medications for high blood pressure, eg. Captopril, enalapril, losartan, valsartan, diltiazem, amlopidine, hydrochlorothiazide, furosemide and many others) – concomitant use may cause excessive decreased blood pressure lowering (hypotensive) effects – should be monitored. Anti-coagulant / anti-platelet drugs – concomitant use may increase the risk of bleeding. Cnidium fructus: no known interactions with diseases or conditions. Catuaba: no known interactions with diseases or conditions. Niacinamide: anti-diabetes drugs – can interfere with blood glucose levels – monitor carefully. Hmg-coa reductase inhibitors (statins) – concommitant use may increase the risk of myopathy. Transdermal nicotine – concommitant use can increase risk of flushing and dizziness.

Pregnancy and lactation:
Not indicated or recommended for use by pregnant or lactating women as safety for use at this time has not been established.

Dosage and directions for use:
Adult dose: one capsule every morning and one capsule every evening.

Side effects and special precautions:
Possible occasional gastro-intestinal complaints or dry mouth may occur.

Not recommended for persons suffering from cardiovascular conditions, diabetes, uncontrolled blood pressure exceeding 180/90.
Patients taking maoi’s should use with caution.
Siberian ginseng can cause slight drowsiness, anxiety, irritability and melancholy (when used in high doses). Should be used with caution in patients with cardiovascular disorders.

L-arginine can cause allergic response or airway inflammation in asthma patients.

Extended use of epimedium may cause dizziness, dry mouth, thirst, nosebleed or vomiting.
Always consult your doctor before taking any new medication.

Known symptoms of overdosage and particulars of its treatment:
Treatment is supportive and symptomatic.

Identification:
Dr long’s enlarged capsules consist of deep yellow hard gelatin capsules, size 00, containing fawn to light-brown coloured powdery contents.

Presentation:
Dr long’s enlarged capsules are presented in the following pack size:
Pack of 30: three blisters of 10 capsules each contained within a printed outer carton.

Storage conditions:
Store below 25 Degree Celcius, protect from moisture. Keep out of reach of children
This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.